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Posted on : 19 April 2017
REGULATORY AFFAIRS SPECIALIST FLEN PHARMA VACANCY FILE Vacancy : REGULATORY AFFAIRS SPECIALIST Contact : Caroline Lamy, HR Manager Full-time/part-time : FT Location : Esch-sur-Alzette (Luxembourg) Starting date : As soon as possible Type of contract : Permanent Flen Pharma: Where Vision meets Reality. Flen Pharma is an international, innovative wound care group with companies based in Luxembourg, Belgium, Netherlands, Germany and UK. In a few years time, it gained a leading position in the Belgian wound care market, its Home market and is working towards reaching this on an international level. This result is due to a twofold reason: (1) dedicated people (2) products combining innovation with significant progress in wound care, inspired by our motto: We help you live the life you love. We are looking for a full time Regulatory Affairs Specialist, for immediate start at our headquarter based in Esch-sur-Alzette (Luxembourg). As a Regulatory Affairs Specialist, you will be responsible for the regulatory affairs processes in countries defined by the Head of Regulatory Affairs and more specifically be in charge of the following tasks in the defined countries: Tasks and responsibilities: " You are responsible for product registration submissions of Flen Pharma s products, renewal approvals, product technical dossiers and other regulatory documents " You are responsible for the regulatory compliance of Flen Pharma s clinical studies, in close collaboration with clinical department " You are responsible for the regulatory compliance of communication activities and material regarding Flen Pharma products, in close collaboration with marketing and sales " You keep abreast of international legislation, guidelines and customer practices by keeping in contact with official institutions " You identify evolving regulatory trends including international trends that are relevant and ensure that appropriate action is initiated " You serve as regulatory contact person for Flen Pharma with distributors and authorities " You monitor the administrative management of translations of the distributed material " You perform a regulatory check of all communicated information e.g. packaging material (brochures, packaging, information for users &) " You will have to work in close collaboration with and report to the Head of Regulatory Affairs Qualifications: " Scientific (ideally university) degree " At least 2 years experience in international medical devices regulatory affairs; knowledge of regulatory affairs related to FDA and other non-EU regulations is an asset " Project management knowledge is an asset " Familiar with MS Office and database applications " Fluency in English is a must, fluency in Dutch is a great asset, fluency in German and/or French is an asset " Proficient in written and oral communication " Accuracy " Analytical ability " Planning & organizing " Quality minded " Autonomous worker " Team player " Diplomatic and open minded Work at Flen Pharma : Flen Pharma is a young and fast-growing, independent organisation with short communication lines, and where entrepreneurship is appreciated. Its products are innovative, patented and are well regarded by the key opinion leaders internationally. Several highly motivated and enthusiastic colleagues have already joined Flen Pharma and contribute to its success. As an expending company, we offer possibilities for personal development and growth.
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